A strong research program requires appropriate experimental design, quality data management and appropriate statistical analysis. The Department of Biostatistics will provide support for the design, conduct and analysis of research studies within the Rochester Area Pepper Center (RAPC). As PI, Dr. Cox will have primary responsibility for the administration of the Biostatistics Core. This includes allocation of resources and assistance with project management. He will also be available to consult on projects as needed, and will specifically work with Dr. Kolassa in Project 1. Dr. Kolassa will have primary responsibility for statistical consulting in Project 1. Dr. Oakes will work with Dr. Griggs in the Research Development core and consult on Project 1. Biostatistical collaboration will include: 1) Collaboration in the development of study protocols. This includes definition of outcome variables and data items required, sources from which they can be collected, sample size calculation, forms design, and implementation of a data management system. 2) Providing assistance during the conduct of the study. This includes patient registration and randomization (if required), entry of data from forms and/or from other computers, software development for quality control, and regular update and interim report generation. 3) Collaboration in the final statistical analysis of the study data. This includes determination of appropriate statistical methodology, production of final reports, tabular and graphical analysis suitable for presentation and publication. The Department of Biostatistics has faculty and staff with expertise in statistics, data management and computing.